DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. V. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 12/472,657, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. More specifically, this application fails to disclose an ‘override device’ and a “barrier”.
The Examiner notes that support for the instant claims has been found in U.S. Provisional Patent Application No. 61/327,792. As such, the Examiner will be taking the priority date for the instant application for the purposes of examination as 4/26/2010, this being the filing date of U.S. Provisional Application No. 61/327,792.
Specification
The disclosure is objected to because the first paragraph does not provide the most current status for the related application. The paragraph should be amended accordingly.
Furthermore, the lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 22 is objected to because of the following informalities: in line 1, “PCT” should be replaced with -PTC-. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a user control for controlling a delivery of energy” in claim 16; “a device configured to prevent a delivery of energy” in claim 16.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
It should be noted that claims 22 and 23 are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph since they recite sufficient structure to perform the recited function.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 27-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. In claim 27, Applicant claims "a barrier that inhibits tissue located between the first and second jaws from moving proximally" which is a positive recitation of the body. Applicant is required to inferentially recite the body. For example, Applicant could say " a barrier that is configured to inhibit tissue from moving proximally between the first and second jaws."
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 27-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 27 recites non-statutory subject matter which alters the scope of the claims.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 16-22 and 24-26 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Goble, U.S. 2003/0139741 (hereinafter Goble).
Regarding claim 16, Goble discloses (note abstract; figs. 15 and 21) a surgical instrument comprising: a jaw assembly (50) for grasping tissue, the jaw assembly having an operative element (bipolar return electrode); a user control (70) for controlling a delivery of energy to the operative element; and a ‘device’ (PTC jaw coating – note paragraphs 17 and 121) configured to prevent a delivery of energy, or reduce an amount of energy being delivered, to the operative element (from the bipolar active electrode) under a predetermined condition after the operative element has been activated, thereby overriding the user control under the predetermined condition.
Regarding claim 17, Goble discloses (see above) a surgical instrument wherein the user control is ‘operatively coupled’ to the operative element (note fig. 15).
Regarding claim 18, Goble discloses (see above) a surgical instrument wherein the device is configured to prevent or slow down the delivery of the energy to the operative element after the operative element has been activated for a predetermined period or after the operative element has reached a predetermined temperature (note paragraph 17).
Regarding claim 19, Goble discloses (see above) a surgical instrument wherein the device is necessarily configured to prevent the delivery of the energy to the operative element for a ‘predetermined duration’ (i.e., until the jaws cool to a set temperature).
Regarding claim 20, Goble discloses (see above) a surgical instrument wherein the predetermined duration is necessarily variable (note paragraph 121).
Regarding claim 21, Goble discloses (see above) a surgical instrument wherein the predetermined duration is necessarily a function of a temperature of the device or of the operative element, a function of an amount of time for which the operative element has been activated, or a function of an actual cool off period undergone by the device or the operative element (note paragraph 121).
Regarding claim 22, Goble discloses (see above) a surgical instrument wherein the device comprises a PTC device configured to allow a current to be delivered to the operative element, and prevent a delivery of the current to the operative element in response to a temperature rise (note paragraphs 17 and 121).
Regarding claim 24, Goble discloses (see above) a surgical instrument wherein the device or the operative element is necessarily configured to increase its resistance to a ‘predetermined resistance value’ in response to the device or the operative element reaching a ‘predetermined temperature’ (note paragraphs 17 and 121).
Regarding claim 25, Goble discloses (see above) a surgical instrument wherein when the device or the operative element reaches the predetermined resistance value, the operative element does not substantially deliver additional energy (until the jaws cool back down to a set temperature - note paragraphs 17 and 121).
Regarding claim 26, Goble discloses (see above) a surgical instrument wherein when the device or the operative element reaches the predetermined resistance value, the operative element delivers additional energy in a predetermined manner (i.e., once the jaws cool back down to a set temperature - note paragraphs 17 and 121).
Claim(s) 16-21 and 23 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Truckai, U.S. 2005/0171535 (hereinafter Truckai).
Regarding claim 16, Truckai discloses (note figs. 1 and 16) a surgical instrument comprising: a jaw assembly for grasping tissue, the jaw assembly having an operative element (bipolar return electrode ‘132A’); a user control (150B) for controlling a delivery of energy to the operative element; and a ‘device’ (NTC matrix ‘322’ – note paragraph 77) configured to prevent a delivery of energy, or reduce an amount of energy being delivered, to the operative element (from the bipolar active electrode on the same jaw) under a predetermined condition after the operative element has been activated, thereby overriding the user control under the predetermined condition.
Regarding claim 17, Truckai discloses (see above) a surgical instrument wherein the user control is ‘operatively coupled’ to the operative element (note fig. 16).
Regarding claim 18, Truckai discloses (see above) a surgical instrument wherein the device is configured to prevent or slow down the delivery of the energy to the operative element after the operative element has been activated for a predetermined period (e.g., almost instantaneously) or after the operative element has reached a predetermined temperature.
Regarding claim 19, Truckai discloses (see above) a surgical instrument wherein the device is necessarily configured to prevent the delivery of the energy to the operative element for a ‘predetermined duration’ (i.e., until the jaws warm up to a set temperature).
Regarding claim 20, Truckai discloses (see above) a surgical instrument wherein the predetermined duration is necessarily variable (note paragraph 77).
Regarding claim 21, Truckai discloses (see above) a surgical instrument wherein the predetermined duration is necessarily a function of a temperature of the device or of the operative element, a function of an amount of time for which the operative element has been activated, or a function of an actual cool off period undergone by the device or the operative element (note paragraph 77).
Regarding claim 23, Truckai discloses (see above) a surgical instrument wherein the device comprises a NTC device configured to provide an electrical resistance, and reduce the electrical resistance in response to a temperature rise (note paragraph 77).
Claim(s) 27-29 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Hixson, U.S. 2007/0173814 (hereinafter Hixson).
Regarding claim 27, Hixson discloses (note figs. 1A and 3A) a surgical instrument comprising: a jaw assembly having a first jaw (110) and a second jaw (120), the first and second jaws movable between an open state and a closed state in which at least a portion of the first and second jaws are closer to each other, wherein a proximal portion of the jaw assembly defines a ‘barrier’ (proximal-most stop members – see fig. 3A) that necessarily ‘inhibits’ (i.e., hinders, restrains) tissue located between the first and second jaws from moving proximally past the barrier when the jaws are in the open state (since these stop members provide some resistance to tissue moving in this direction); and an operative element (112/122) for applying energy to tissue, wherein the operative element is located at the jaw assembly, wherein the operative element extends along the jaw assembly from the barrier to a location that is distal of the barrier.
Regarding claim 28, Hixson discloses (see above) a surgical instrument wherein the operative element extends along the jaw assembly from a location proximal of the barrier to the location that is distal of the barrier (note fig. 3A).
Regarding claim 29, Hixson discloses (see above) a surgical instrument wherein the operative element includes an electrode (112/122).
Claim(s) 27 and 29-32 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Johnson, U.S. 2005/0113826 (hereinafter Johnson).
Regarding claims 27 and 29, Johnson discloses (note figs. 1A and 3C) a surgical instrument comprising: a jaw assembly having a first jaw (110) and a second jaw (120), the first and second jaws movable between an open state and a closed state in which at least a portion of the first and second jaws are closer to each other, wherein a proximal portion of the jaw assembly defines a ‘barrier’ (formed by the proximal junction of the tissue-contacting surfaces) that necessarily inhibits tissue located between the first and second jaws from moving proximally past the barrier when the jaws are in the open state; and an operative element (see electrodes in fig. 3C) for applying energy to tissue, wherein the operative element is located at the jaw assembly, wherein the operative element extends along the jaw assembly from the barrier to a location that is distal of the barrier.
Regarding claim 30, Johnson discloses (see above) a surgical instrument wherein the electrode includes a first portion (412/422) capable of welding tissue, and a second portion (427a-b) capable of cutting tissue.
Regarding claim 31, Johnson discloses (see above) a surgical instrument wherein the first portion (412a-b) is coupled to the first jaw, and the second portion (427b) is coupled to the second jaw.
Regarding claim 32, Johnson discloses (see above) a surgical instrument wherein the first (412a-b) and second (427a) portions are coupled to the first jaw.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. 2005/0096651 (Truckai).
U.S. 2005/0203507 (Truckai).
U.S. 6,770,072 (Truckai).
U.S. 2005/0137590 (Lawes).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794